Fexofenadine HCL by CVS FEXOFENADINE HCL tablet

Fexofenadine HCL by

Drug Labeling and Warnings

Fexofenadine HCL by is a Otc medication manufactured, distributed, or labeled by CVS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms:
 trouble swallowing  dizziness or loss of consciousness
 swelling of tongue  swelling in or around mouth
 trouble speaking  wheezing or problems breathing
 drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later

Not a Substitute for Epinephrine.

If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

 to prevent hives from any known cause such as:
 foods  insect stings  medicines  latex or rubber gloves because this product will not stop hives from occurring. Avoiding the
cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives,
see your doctor for a medical exam. Your doctor may be able to help you find a cause.
 if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

 kidney disease. Your doctor should determine if you need a different dose.

 hives that are an unusual color, look bruised or blistered
 hives that do not itch

When using this product

 do not take more than directed
 do not take at the same time as aluminum or magnesium antacids
 do not take with fruit juices (see Directions)

Stop use and ask a doctor if

 an allergic reaction to this product occurs. Seek medical help right away.
 symptoms do not improve after 3 days of treatment
 the hives have lasted more than 6 weeks

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age: do not use

adults 65 years of age and older: ask a doctor
consumers with kidney disease: ask a doctor

Other information

 safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.
 store between 20° and 25°C (68° and 77°F)
 protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Principal display panel

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-767
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	orange ((peach))	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	G6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-767-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	03/27/2024

Labeler - CVS (062312574)